FDA Device Establishments · JSON-LD · Markdown
FEI 3009963139 · Export Device to the United States But Perform No Other Operation on Device Repack or Relabel Medical Device · Status: Active
| FEI Number | 3009963139 |
|---|---|
| Owner / Operator | Kuehne GmbH (#10088909) |
| Address | Beratgerstr. 19, Dortmund North Rhine-Westphalia, 44149, DE |
| Mandatory US Agent | Block Imaging |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | IZI, OWB, JAA |
| Regulation § (21 CFR) | 892.1600, 892.1650 |
| Proprietary names | Allura Xper FD20/20 |
Source: openFDA. Public-domain (CC0).